Drugs / Ocriplasmin
Ocriplasmin
also known as
Microplasmin · JETREA · Microplasmin (synthetic human) · Ocriplasmina · Ocriplasmine · Plasmin, micro- (synthetic human) · Recombinant human microplasmin
Protein / enzyme biologic targets FN1
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed secondary vitreoretinal degeneration 1 milestone | |||||
| Filed | EU (EMA) | JETREA® | secondary vitreoretinal degeneration | — | “The JETREA European Marketing Authorisation Application is currently under review by the European Medicines Agency.” bioinvent.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Jetrea | — | 2023-08-30 | europa.eu ↗ |
| Label expansion | US (FDA) | JETREA | — | 2014-06-13 | fda.gov ↗ |
| Approved | EU (EMA) | Jetrea | — | 2013-03-13 | europa.eu ↗ |
| Approved | US (FDA) | JETREA | — | 2012-10-17 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02747030 | Dec 2016 → Aug 2017 | central retinal vein occlusion | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01194674 | Jan → Dec 2011 | uveitis | National Institutes of Health Clinical Center (CC) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 213 trials · 5 missed | ||||||
| Phase 2 | NCT02681809 | Dec 2015 → Nov 2019 | diabetic retinopathy, vitreous detachment | ThromboGenics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01159665 | Jul → Nov 2010 | — | ThromboGenics | Completed | No outcome recorded |
| Phase 2 | NCT00986362 | Feb 2010 → Dec 2011 | — | ThromboGenics | Completed | Missed primary |
| Phase 2 | NCT01055535 | Jan 2010 → Apr 2011 | — | ThromboGenics | Completed | No outcome recorded |
| Phase 2 | NCT00913744 | Jan 2010 → Dec 2012 | wet macular degeneration | ThromboGenics | Completed | Missed primary |
| Phase 2 | NCT00996684 | Oct 2009 → Sep 2011 | macular degeneration | University of California, Los Angeles | Unknown | No outcome recorded |
| Phase 2 | NCT00428129 | Mar 2007 → Jul 2008 | venous thromboembolism | ThromboGenics | Terminated | No outcome recorded |
| Phase 2 | NCT00435539 | Feb 2007 → Jan 2009 | vitreous detachment | ThromboGenics | Completed | Missed primary |
| Phase 2 | NCT00412451 | Dec 2006 → Jan 2010 | diabetic macular edema | ThromboGenics | Completed | Missed primary |
| Phase 2 | NCT00412958 | Dec 2006 → Oct 2008 | — | ThromboGenics | Completed | Missed primary |
| Phase 2 | NCT00123266 | Dec 2006 → Jul 2007 | large artery stroke | ThromboGenics | Terminated | No outcome recorded |
| Phase 2 | NCT00123292 | Mar 2005 → Jun 2007 | arterial occlusion | ThromboGenics | Terminated | No outcome recorded |
| Phase 2 | NCT00123279 | Dec 2004 → Feb 2007 | eye disorder | ThromboGenics | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT01889251 | Jul 2013 → Sep 2014 | vitreous detachment | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT01429441 | Oct 2011 → Oct 2014 | macular holes | ThromboGenics | Completed | No outcome recorded |
| Phase 3 | NCT00781859 | Dec 2008 → Mar 2010 | vitreous detachment | ThromboGenics | Completed | Met primary |
| Phase 3 | NCT00798317 | Dec 2008 → Jun 2010 | vitreous detachment | ThromboGenics | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT02322229 | May → Dec 2015 | vitreoretinal degeneration, vitreous detachment | Alcon Research | Completed | No outcome recorded |
| Phase 4 | NCT02035748 | Apr 2014 → Sep 2015 | — | Alcon Research | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00123305 Comparator | Oct 2005 → May 2008 | ischemic stroke | ThromboGenics | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-12-08 | ThromboGenics | ThromboGenics – Patient Enrolment in Phase II CIRCLE Study Evaluating THR-409 (ocriplasmin) for Non-Proliferative Diabetic Retinopathy Discontinued due to Slow Recruitment Rate oxurion.com ↗ |
| 2017-09-18 | ThromboGenics | ThromboGenics Regains Global Rights to JETREA® (ocriplasmin) oxurion.com ↗ |
| 2017-08-16 | ThromboGenics | New Ocriplasmin Clinical and Health Economic Data Presented at ASRS 2017 in Boston oxurion.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ocriplasmin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00435539 ↗ |
| Known as | JETREA | “The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.” NCT02035748 ↗1“Vitreomacular traction (VMT) treatment options include watchful waiting, vitrectomy and intravitreal ocriplasmin injection (Jetrea®).” PMID 30350717 ↗ Oct 2018 |
| Known as | Microplasmin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00123279 ↗ |
| Known as | Microplasmin (synthetic human) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095222 ↗ |
| Known as | Ocriplasmina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095222 ↗ |
| Known as | Ocriplasmine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095222 ↗ |
| Known as | Plasmin, micro- (synthetic human) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095222 ↗ |
| Known as | Recombinant human microplasmin | ChEMBL registry synonym — accepted as the source's own label CHEMBL2095222 ↗ |
| Modality | Protein / enzyme biologic | “microplasmin, a proteolytic enzyme” NCT00996684 ↗ |
| Route | Other | “2 mg/kg, IA over 75 mins” NCT00123266 ↗ |
| Target | FN1 | “Fibronectin proteolytic enzyme” CHEMBL2095222 ↗ |